Tuesday, October 2, 2012

Novartis launches pasireotide for Cushing’s disease

Cushing’s disease patients for whom surgery is not a viable option have a new treatment alternative, in the form of the orphan medicine pasireotide.

Launched by Novartis as Signifor, the drug is a somatostatin analogue that blocks the release of excessive adrenocorticotropic hormone, thus reducing cortisol levels.

Pasireotide is available as a solution for injection that should be self-administered by the patient twice a day. Patients should be informed how to inject the drug under the skin and that using the same injection site for two consecutive injections is not recommended.

After two months of treatment, patients’ blood cortisol levels are measured to determine whether treatment should continue, and at what dose (see Panel).

Patients who experience adverse reactions may need to temporarily lower their twice-daily dose, with decrements of 0.3mg suggested in the summary of product characteristics.

Pasireotide is indicated for adults only and is contraindicated for use by patients with severe liver impairment. It should be used with caution by patients who are taking medicines that prolong the QT interval, and clinical monitoring of heart rate is recommended for patients receiving pasireotide concomitantly with bradycardic drugs.

Dose adjustments of ciclosporin, insulin and antidiabetic medicines may be required if these are taken concomitantly with pasireotide.

The EMA granted marketing authorisation for pasireotide in April 2012 on the basis that, although the proportion of patients who responded to treatment in clinical trials was small (around 15 per cent), a partial response may be of benefit to patients whose condition cannot be managed with surgery.

Product information

Class: Somatostatin analogue

Dose: 0.6mg by subcutaneous injection twice daily. After two months of treatment, patients whose urinary free cortisol levels have reduced can continue treatment for as long as they experience a benefit. The dose can be increased to 0.9mg as long as the 0.6mg dose is well tolerated. Patients who have not responded after two months of treatment should be considered for discontinuation. The recommended twice-daily dose for patients with moderate liver impairment is 0.3mg initially, up to a maximum of 0.6mg.

NHS list price: 60 x 0.3mg/ml, £2,800; 60 x 0.6mg/ml, £3,240; 60 x 0.9mg/ml, £3,240

Legal category: POM 

From PJOnline